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NCT Number: NCT02029339

Continuous Topical Instillation for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections

The closed systems, such as conventional negative pressure wound therapy (NPWT), were usually avoided in infected or critical colonized wounds. To our observation, the additional continuous irrigation tube attached beside the suction tube in the NPWT system could provide the effective drainage by reducing the occlusion of suction tube, enable effective debridement by diluting infected/necrotized tissues and decrease the incidence of fistula by providing relatively moist ambient. At our institutions, the modified system combined with a "triple-tube" device to allow a continuous instillation became more active and efficient. The study is to investigate if a continuous triple-tube instillation and suction could improve the outcomes of acute severely infected open abdomen.

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Key information

Conditions

Wound Infection Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Zhongda Hospital, Southeast University Medical School

Nanjing, Jiangsu, 210089, China

About this study

This study was performed on the patients with a severely complicated infected open abdomen treated with topical triple-tube irrigation and suction, compared with a control group of the patients treated with standard NPWT without topical irrigation. The clinical outcomes were recorded. Profiles of cytokines/proteinase in wound fluid were quantified weekly.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18 years patients with complicated intra-abdominal infections who needed open abdomen (OA) and vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM)
  • Eligible patients were properly consented before enrollment. If the patient was incapable, the patient's legal representative was asked to provide consent on the patient's behalf.
  • Patients with grade 1b (contaminated OA without adherence between bowel and abdominal wall), 2b (contaminated OA developing adherence) open abdomen, as classified by Bjorck.

Exclusion criteria

  • < 18 years,
  • pre-existing large ventral hernia
  • Frozen OA with adherent bowel (OA of grade 4),
  • Clean wound (OA of grade 1a or 2a)
  • chronic wound infection
  • critical wound ischemia
  • severe systemic infection
  • end-stage renal disease
  • severe liver disease
  • uncontrolled diabetes mellitus
  • any issue with an obviously high risk of delayed wound healing

Treatment and study plan

Continuous topical triple-tube irrigation and suction

Device

The triple-tube device was continuous operated: instilled the topical solution through the "washing tube", delivered negative pressure therapy at 100 - 125 mmHg continuously through the inner tube of "sleeve tubes" through the central negative pressure device in the wall of the ward. The outer tube was used for normalize and balance the distribution of the negative pressure around the inner tube to allow the solution to penetrate through the dressing to cover the wound, and protecting the inner tube from getting stuck with the sucked tissue. All tubes are all commercially available (Medical Silicone Tubing, Forbest Manufacturing Co., Ltd, China).

SOC

Device

Debridement, offloading, standard moist wound care, and conventional NPWT without continuous irrigation are the fundamental SOC for Open Abdomen with complicated abdominal infections.

Other names: standard of care

Primary outcomes

  1. Delayed primary fascial closure

    Time frame: Up to 8 weeks

    Delayed primary fascial closure, Time to infection clearance and abdomen closure, ICU and hospital length of stay

Secondary outcomes

  1. Levels of cytokines/proteinase in wound fluid

    Time frame: Up to 8 weeks

    Wound fluid was collected at the initial admission and every three days later. Before samples were collected, irrigation was released and held for 6 hours to avoid contamination or dilution by the washed solution. Wound fluid was collected using a filter paper (PerioPaper, Oraflow Inc., NY) for 30 seconds as prior described and stored at -80°C until analyses.

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Continuous Topical Triple-tube Instillation and Suction for for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections

Acronym: Triple-tube

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2014
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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